The Office of Management and Budget (OMB) recently released the Fall 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS), Animal and Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS). After highlighting the most significant priorities, we provide charts for each agency that provide additional details on their plans. More information can be found by clicking on the blue link next to each item, which will take you to a specific page about each agenda item on OMB’s website.

We want to caution that the dates included in the Unified Agenda are not commitments to act on or by the date shown and simply indicate the agencies’ aspirations (note, for example, that dates for some planned actions have already passed). Rather than focusing on projected dates, the Unified Agenda is a valuable tool to identify the substantive issues the agencies consider to be priorities for rulemaking.

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The Federal Communications Commission (FCC), in consultation with the Department of Agriculture, announced the members of the Task Force for Reviewing the Connectivity and Technology Needs of Precision Agriculture in the United States (Task Force). The Task Force, an advisory body to the FCC, will investigate the current state of broadband access in agricultural lands and recommend policies and regulatory solutions to the FCC to promote broadband deployment and precision agriculture, standardize data collections, and target funding towards unserved areas.  The Task Force is also slated to identify ways for the Department of Agriculture and the FCC to collaborate to achieve these shared goals.

Teddy Bekele, Land O’Lakes Senior Vice President and Chief Technology Officer, will serve as Chair of the Task Force, and Catherine Moyer, Pioneer Communications Chief Executive Officer and General Manager, will serve as Vice Chair. A full list of members is included in this Public Notice. The first meeting of the Task Force is scheduled for Monday, December 9, 2019, at 9:30 a.m., and is open to the public.

In addition to announcing the members of the Task Force, the FCC released another Public Notice soliciting nominations for four working groups charged with assisting the Task Force. Those working groups are: (1) Mapping and Analyzing Connectivity on Agricultural Lands, (2) Examining Current and Future Connectivity Demand for Precision Agriculture, (3) Encouraging Adoption of Precision Agriculture and Availability of High-Quality Jobs on Connected Farms, and (4) Accelerating Broadband Deployment on Unserved Agricultural Lands.  The Public Notice provides instructions on eligibility for the working groups and how to submit nominations. Nominations to the working groups are due by Tuesday, December 3, 2019.

On October 31, 2019, the United States Department of Agriculture (USDA) published an interim final rule (IFR) on domestic hemp production. This rule establishes a regulatory framework for USDA oversight of domestic hemp production in accordance with the 2018 Farm Bill.  While many questions remain about how the federal government, including the U.S. Food and Drug Administration (FDA), will regulate hemp-derived products, including cannabidiol (CBD) cosmetics, dietary supplements, and food products, we’ve addressed below the most important takeaways from the IFR with regard to the provisions that would apply to the farmers who are growing hemp.

Scope of Interim Final Rule

The scope of the IFR is limited to the production, sampling, testing, and disposal of hemp plants. The 2018 Farm Bill and the IFR’s requirements (licensing, etc.) apply to hemp producers, and the regulations define producers as, essentially, farmers that grow (or cultivate) hemp plants for market. In other words, the USDA is not regulating the processing, manufacture, testing, or
marketing of hemp-derived products (including CBD products) through the IFR. FDA retains authority over the manufacturing and marketing of CBD, and other cannabinoid-containing pharmaceuticals, foods, dietary supplements, and cosmetics, and the federal Drug Enforcement Administration (DEA) retains jurisdiction over any plants or products that contain greater than 0.3% THC on a dry weight basis. USDA also reiterates that states may not prohibit the transportation or shipment of hemp produced in accordance with the IFR (and the 2018 Farm Bill) or the 2014 Farm Bill.

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On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to contract manufacturers (“co-manufacturers). The agency is taking this action to address situations where brand owners perform certain supply-chain program requirements on behalf of their co-manufacturers. This action extends the enforcement discretion FDA announced in November 2017, which was due to expire on November 6, 2019. Notably, FDA has not yet announced the length of time for this extension of the enforcement discretion but plans to do so in a forthcoming Federal Register notice. This memorandum provides a background on this issue and explains the FDA’s recent announcement.


Under the Preventive Controls for Human Food and Preventive Controls for Animal Food (collectively, “Preventive Controls”) regulations, a supply-chain program is required when a receiving facility identifies a hazard requiring a preventive control that is controlled before an ingredient’s receipt by the facility. A co-manufacturer is considered a “receiving facility” under the rule. Although the co-manufacturer is responsible for approving its suppliers when a supply-chain program is required, there is some flexibility in the rule that allows the co-manufacturer to rely on a brand owner’s supply-chain program activities.

Specifically, the supply-chain program provisions in the Preventive Controls regulations provide that another entity (such as a brand owner) can determine, conduct or both determine and conduct
appropriate supplier verification activities on behalf of an entity such as a co-manufacturer, provided that the co-manufacturer documents its review and assessment of the brand owner’s applicable supplier verification documentation. Thus, when a co-manufacturer relies on a brand owner to handle supplier verification activities, the co-manufacturer will need detailed information from the brand owner in order to meet its own obligations under the supply-chain program regulations. Industry has expressed concerns to FDA that these requirements may not be feasible.

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The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA). The Proposed Rule establishes a new program whereby certain food testing must be performed by laboratories accredited by an FDA-recognized accreditation body. The accredited laboratories would be required to send the results of testing conducted under this rule directly to FDA.

FDA proposes that use of an accredited laboratory would be required: (1) for nine specific existing regulatory testing requirements that apply to bottled water, shell eggs, and sprouts; (2) if the agency issues a “food testing order;” (3) for certain test results presented to FDA in connection with certain serious agency enforcement actions (e.g., mandatory food recalls); and (4) for certain testing involving imports. A food testing order would be a new regulatory tool whereby FDA would have broad authority to require an owner or consignee of food to perform food product or environmental testing in response to an identified or suspected food safety problem.

This memorandum summarizes the key aspects of the Proposed Rule, with a focus on the impacts on food manufacturers and importers. Note that the preamble includes a number of tentative conclusions and questions for comment that warrant careful review, but which are beyond the scope of this memorandum. Comments on the Proposed Rule are due March 3, 2020.

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The amendment to the General Health Law concerning overweight, obesity, and Front Labeling Warnings for prepackaged food and non-alcoholic beverages will become into force, as per its publication in the Official Federal Gazette (FOG) on November 8, 2019.

The referred amendment main purpose is to establish new provisions and guidelines regarding those legends, pictograms and warning symbols that the labeling of prepackaged food and non-alcoholic beverages shall contain in case these products exceed maximum levels of (i) energetic content, (ii) added sugars, (iii) saturated fats, (iv) fats, (v) sodium, and (vi) critical nutrients and ingredients as determined by the Ministry of Health.

Critical nutrients are defined as those that deemed to represent a risk factor for chronic diseases.

The referred amendment to the General Health Law will become into force on November 9, 2019. The Executive Power shall adopt those necessary changes to the regulatory framework (e.g., Regulations, Mexican Official Standards, etc.) by no later than May 6, 2020.

As part of the related regulatory modifications, the draft amendment of Mexican Official Standard NOM-051-SCFI-SSA1-2010, General labeling specifications for prepackaged food products and non-alcoholic beverages-Commercial and sanitary information, was published in the FOG on October 11, 2019. To this end, any interested party is allowed to formally file comments regarding the relevant new labeling requirements for prepackaged food and non-alcoholic beverages. The deadline for submitting comments is December 10, 2019.

The Regulatory team at Hogan Lovells is ready to assist you and clarify any questions you have on this matter.

The Food and Drug Administration (FDA) issued a final rule to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The final rule requires such calorie declarations to be at least 150 percent the size of the net quantity of contents statement as required under 21 C.F.R. § 101.7(i) (i.e., 1.5 x the size of the net weight). FDA proposed this change to the type size requirements in July 2018, after industry expressed concerns that the previous type size requirement for FOP calorie declarations – at least 50 percent of the size of the largest printed matter on the label – was impractical, needlessly burdensome, and would disrupt existing voluntary industry front-of-pack nutrition labeling programs. The compliance date for the new font size requirement is July 1, 2021. FDA also announced it will continue its enforcement discretion with respect to the vending machine labeling requirements as applied to gums, mints, and roll candy products sold in glass-front machines in packages that are too small to bear FOP labeling.

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On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are being made in FDA’s implementation of the FDA Food Safety Modernization Act (FSMA).1 FDA will use input from the meeting and written comments to the docket to develop a Blueprint for a New Era of Smarter Food Safety, which the agency plans to release in early 2020. The Blueprint will outline the agency’s vision for a modern approach to food safety that includes technology-enabled traceability and the use of predictive analytic tools to assess risk and set agency priorities. FDA has opened a docket for written comments, which are due by November 20, 2019.2 The specific questions on which FDA has requested input are included as an appendix to this memo and provide insight into FDA’s current thinking on these issues. The discussion below provides a high-level summary of the agency statements and stakeholder comments made during the meeting.

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Today, the U.S. Food and Drug Administration (FDA) updated its “Industry Resources on the Changes to the Nutrition Facts Label” webpage questions and answers,1 stating that the agency does not intend to take enforcement actions related to the new nutrition labeling requirements for the first six months following the January 1, 2020 compliance date for businesses with more than $10 million in annual food sales.2 FDA explains that it has received several requests for additional time to comply with the new nutrition labeling requirements, and accordingly intends to work cooperatively with industry for the first 6 months following the compliance date:

I understand that the FDA has received multiple requests from manufacturers to provide additional time to comply with the new requirements. Do I still have to meet the January 1, 2020, compliance date?

The FDA has heard from several manufacturers and groups that more time may be needed to meet all of the requirements. Therefore, during the first 6 months following the January 1, 2020, compliance date, FDA plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time.

The agency statement provides the industry with much-needed flexibility to facilitate a seamless transition to the new labels. We would encourage companies to maintain their diligence in transitioning to the new labels so that the entire inventory will be transitioned during the first six months of 2020. We will continue to monitor the FDA’s implementation of the new nutrition labeling requirements. If you have questions on this or any other matter, please contact us.

1 See Industry Resources on Changes to the Nutrition Facts Label, available at industry-resources-changes-nutrition-facts-label#Compliance.
2 For more information on the compliance date for the nutrition labeling final rules, see our memo, available at For manufacturers with less than $10 million in annual food sales, the compliance date is January 1, 2021.

On October 10, 2019, the Draft Amendment to the Mexican Official Standard NOM-051-SCFI/SSA1-2010, General Labelling Specifications for Prepackaged Foods and Non-Alcoholic Beverages-Commercial and Health Information (NOM-051) was published in the Federal Official Gazette (DOF).

The aforementioned publication derives from the amendment process which is subject to the referred Mexican Official Standard. As part of such process, any individuals and/or stakeholders have a 60 calendar-day period for the submission of any comments regarding the contents of the draft amendment to the NOM-051, before the National Advisory Committee on Standardization of the Ministry of Economy (CCNNSE, by its initials in Spanish).

Upon the conclusion of the period, the CCNNSE shall analyze all the comments received and, if applicable, it shall modify the Draft Amendment to the NOM-051 within a period which shall not exceed 45 calendar days.

Subsequently, the answers to the individuals’ comments and, where applicable, the modifications to the Draft Amendment to the NOM-051 shall be published in the DOF, at least 15 calendar days prior to the date when the publication of the Mexican Official Standard NOM-051 intends to be published in the DOF for becoming into force.

The Draft Amendment to the NOM-051 that was published last Friday is aligned with the publication that was made in the website of the National Commission for Regulatory Improvement, last October 7 in terms of the draft amendment, the following shall be emphasized:

i. It introduces new applicable terms and definitions, such as sugar added and sugar-free, natural or artificial sweetener, front labeling system; supplementary nutrition facts, children, critical nutrient, genuine and substitute products, warning stamp, among others.

ii. It now forbids the use of legends, which refer to recommendations or endorsements by professional companies or associations.

iii. The use of characters, drawings, celebrities, gifts, offers, toys, or contests is now forbidden for certain product categories.

iv. Likewise, the new draft amendment now limits the advertising of certain product categories in social media.

v. New rules apply for the use and declaration of the denomination of foods, mainly in terms of genuine and substitute products.

vi. Furthermore, the draft amendment sets out new guidelines for the declaration of ingredients, among which, the following stand out:

  • Declaration of sugars, their categories, and quantities.
  • Declarations of allergens and ingredients that may cause hypersensitivity and/or intolerance, including new categories (e.g. syrups).
  • Tighter regulations for additives.

vii. Draft amendments introduce the obligation to declare added sugars and trans-fats as part of the Nutritional Declaration of products.

viii. It now broadens the supplementary nutritional facts chapter.

ix. Adopts the Front Labeling System,  the purpose of which is to warn and inform the consumer regarding such nutrients which, pursuant to the provisions of the NOM, constitute a health risk. For example:

  • The use of warning stamps in connection to nutrients (for example: “Excess Calories”).
  • The use of warning stamps in connection to sweeteners (for example: “It contains sweeteners, it should be avoided in children”).
  • Precautionary legends (for example: “It contains caffeine, it should be avoided in children”).

x. Finally, the draft amendment provides for a Conformity Assessment Procedure, and now introduces the obligation to obtain the relevant compliance opinion.

The Hogan Lovells Global Regulatory team is ready to assist you and clarify any questions you have on this matter.